Events

Rappel de Lifestent Vascular Stent System (200 mm stent length)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01038-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-10
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01038-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    After successful introduction of an optimised delivery system design, the device manufacturer angiomed has determined that the optimised lifestent solo vascular stent systems have a significantly lower incidence rate of partial stent deployment associated with their use compared to the original lifestent vascular stent system. the manufacturer, angiomed, has determined that due to the number of lifestent vascular stent system original design devices still available in consignment and customer inventory positions, and the improved performance of the lifestent solo vascular stent system optimized design, a recall action related to the original design product is warranted. this measure will provide customers and patients the lifestent solo optimized stent delivery system performance.
  • Action
    Customers are requested to inspect their stock and quarantine any product from the affected lots. Bard will arrange for the return and replacement of affected stock. No medical or surgical interventions and no monitoring measures are required for LifeStent Vascular Stents which have already been implanted, as the reported partial stent deployments occurred during the release of the stent from the delivery system.

Device

Lifestent Vascular Stent System (200 mm stent length)
  • Modèle / numéro de série
    Lifestent Vascular Stent System (200 mm stent length)Product Code: EX072001L, EX072003L Lots: ANVK0073, ANWB0773, ANWC3759, ANWC3760ARTG: 160453
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd